NRG Oncology Network Group Operations Center

NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-RTOG 1216 BIQSFP Project Title: Integral Determination of p16 Expression in Oropharyngeal Carcinoma as an Eligibility Criterion BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 0; Total # planned for entire BIQSFP project: 135 (no invoices have been received to date for screening activities) • # of patients expected to be screened/tested during the reporting period: 10 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: p16; # tests expected to be completed: 6 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? o Accrual for this study has been acceptable with 60 patients expected to be enrolled in grant year 10. The need for confirmation of p16 status for the nasopharyngeal patients has not occurred at the rate originally projected and therefore less funds have been expended than originally projected. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN003 BIQSFP Project Title: pHH3 Mitotic Index as an Integrated Marker BIQSFP entire project duration: 2017 to 2025 • Total # screened/tested to date: 184; Total # planned for entire BIQSFP project: 222 • # of patients expected to be screened/tested during the reporting period: 24 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: pHH3; # tests expected to be completed: 24 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? No (see below). • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? o The sample size for this trial was increased from 133 to 163 patients in a June 2022 protocol amendment due to the higher number of patients than expected withdrawing consent for treatment with RT on the trail. Based on current screening patterns it is expected that 222 patients will be needed to meet the new sample size for the intervention step. . December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN007 BIQSFP Project Title: O6-methylguanine DNA methyltransferase gene (MGMT) promoter methylation testing by MGMT-STP27 BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 374; Total # planned for entire BIQSFP project: 750 • # of patients expected to be screened/tested during the reporting period: 0 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: MGMT-STP27; # tests expected to be completed: 0 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? The study was permanently closed to accrual in June 2023 as the results of the Phase II futility analysis did not meet the threshold to move the protocol to the Phase III portion. The trial closed with 374 patients screened and 159 of those patients enrolled on step 2 treatment intervention arms December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN009 BIQSFP Project Title: Real Time Integrated Neurocognitive Function Study Comparing Neurocognitive Function with the Clinical Trial Battery in Patients with High Brain Met Velocity Treated with SRS or SRS + HA-WBRT, NRG BN009 BIQSFP entire project duration: 2021 to 2026 • Total # screened/tested to date: 14; Total # planned for entire BIQSFP project: 350 • # of patients expected to be screened/tested during the reporting period: 10 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Neurocognitive Tools; # tests expected to be completed: 10 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? No If “no,” please explain. o This study opened for patient enrollment in December of 2020 and accrual for the last three years was significantly slower than the 10 patients per month which was expected. To improve accrual the study team amended the trial in April 2023 and made the following changes:  The stereotactic radiosurgery (SRS) plus hippocampal-avoidant whole brain radiotherapy (HA-WBRT) arm was modified to be HA-WBRT alone. The NRG-BN009 team and the NRG Brain Tumor Committee leadership felt that modifying this arm will remove insurance barriers and significantly increase physician and patient enthusiasm for the study, and thereby accrual without changing the. fundamental scientific question being addressed, which is the comparison of a focal irradiation approach (Salvage SRS alone) versus a HA-WBRT approach (extensive field irradiation). The primary hypothesis that the latter strategy will improve freedom from neurologic death will not be affected by this amendment.  In addition, the protocol was revised to allow patients to have undergone multiple SRS treatments to different brain metastases as long as prior brain metastasis velocity (BMV) has been less than 4 brain metastases/year. This change was made because presentation with high BMV, and not number of prior SRS treatments, is central to the primary hypothesis being tested.  Lastly, the protocol eligibility was changed to permit enrollment of patients with prior small cell cancer, as prior small cell cancer was included in the multiple series that demonstrated the importance of BMV. • Do you anticipate a need to extend the study period? Yes If “yes,” please explain. o This study was originally projected to complete accrual and testing during 2026. If the amendment detailed above is successful in improving accrual an extension to the BIQSFP will be required. If the accrual does not improve the trial will be closed without meeting its required sample size. The decision regarding study closure will be made during grant year 11. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? Yes o The budget has been modified to reflect the slow accrual to this study and the decreased effort required for neurocognitive testing. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-BN011 BIQSFP Project Title: “O6-methylguanine DNA methyltransferase gene (MGMT) promoter methylation testing by MGMT-STP27 BIQSFP entire project duration: 2021 to 2025 • Total # screened/tested to date: 204; Total # planned for entire BIQSFP project: 1110 • # of patients expected to be screened/tested during the reporting period:150 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: MGMT; # tests expected to be completed: 150 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? o Accrual has been slower than expected for this study but it is still within the CTEP required accrual guidelines. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN001 BIQSFP Project Title: Integral determination of pre- and post-treatment EBV DNA in EBV+ nasopharyngeal carcinoma for risk group stratification BIQSFP entire project duration: 2020 to 2024 • Total # screened/tested to date: 828; Total # planned for entire BIQSFP project: 828 (The study closed to accrual in July 2023 and the last patient underwent testing in October 2023) • # of patients expected to be screened/tested during the reporting period: 18 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Eligibility & Post RT EBV DNA; # tests expected to be completed: 18* • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? This study is now closed to patient accrual and all EBV DNA testing is completed. Final invoicing and testing reconciliation is now in progress. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN006 BIQSFP Project Title: Determining Negative Predictive Value of FDG PET/CT for N0 Neck in T1-T2 Oral Cavity SCC Patient BIQSFP entire project duration: 2020 to 2025 • Total # screened/tested to date: 254; Total # planned for entire BIQSFP project: 560 • # of patients expected to be screened/tested during the reporting period: 100 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: FDG PET/CT; # tests expected to be completed: 100 • • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. Do you anticipate a need to extend the study period? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? No December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report Study Number: NRG-HN011 BIQSFP Project Title: Tumor-derived plasma EBV DNA-guided optimal maintenance immunotherapy for Epstein-Barr Virus-associated recurrent and/or metastatic nasopharyngeal carcinoma. BIQSFP entire project duration: 2023 to 2027 • Total # screened/tested to date: 0; Total # planned for entire BIQSFP project: 184 • # of patients expected to be screened/tested during the reporting period: 6 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: EBV DNA; # tests expected to be completed: 0 • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. • Do you anticipate a need to extend the study period? No If “yes,” please explain. • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? This study is expected to open for accrual in January 2024. December 2023 NCI CCCT Biomarker, Imaging, & QOL Studies Funding Program (BIQSFP) Annual Progress Report – Grant Year 10 Study Number: NRG-GU005 BIQSFP Project Title: Evaluating response to moderate hypofractionation vs. SBRT in NRG GU005 based on Decipher Genomic Classifier Integrated Biomarker BIQSFP entire project duration: 2022 to 2024 • Total # screened/tested to date: 30; Total # planned for entire BIQSFP project: 550 • # of patients expected to be screened/tested during the reporting period: 150 • # of assay/tests expected to be completed during reporting period IF different from # of patients tested (e.g., multiple time points are tested per patient). If multiple time points were involved, please include # of tests per time point in description assay/test name and description: Decipher GC Score; # tests expected to be completed: 550 • • Were there any unanticipated issues that negatively impacted conducting the BIQSFP-funded assays/tests within projected turn-around time? No If “yes,” please explain. • Are patient accrual and completion of BIQSFP-funded assays/tests progressing on schedule? Yes If “no,” please explain. Do you anticipate a need to extend the study period? No If “yes,” please explain. • Are there any other issues or concerns that should be brought to NCI’s attention? No A pilot run of 30 samples was sent from the NRG UCSF Biobank in December 2023 to Veracyte (Decipher). If they are processed successfully, future batches of 30 samples will be sent every two weeks for processing. All processing will be completed during year 11 of the grant. December 2023